PAIN AND ITCH RELIEF 4% LIDOCAINE (LIDOCAINE) CREAM [WALGREENS]

PAIN AND ITCH RELIEF 4% LIDOCAINE (LIDOCAINE) CREAM [WALGREENS]
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NDC 0363-3001-24
Set ID f84e76a9-6af6-4fd1-be4e-efa05728cbfd
Category HUMAN OTC DRUG LABEL
Packager Walgreens
Generic Name
Product Class Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number PART348
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Lidocaine 4%

  • Purpose

    Topical analgesic

  • Use

    for the temporary relief of pain associated with minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritations

  • Warnings

    For external use only.

    Avoid contact with eyes.

    Not for prolonged use.

    Do not use in large quantities, particularly over raw surfaces or blistered areas.

    Stop use and ask a doctor if

    • condition worsens
    • symptoms persist for more than 7 days or clear up and occurs again within a few days
    • rash or irritation develops, persists, or increases

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away: 800-222-1222.

  • Directions

    Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily

    Children under 2 years of age: Consult a doctor

  • Other information

    • store at 15 to 30°C (59 to 86°F)
    • Tamper Evident: DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING.
  • Inactive ingredients

    aloe barbadensis leaf juice, arginine, benzophenone-4, caprylyl glycol, cetyl alcohol, dimethyl sulfoxide, hexylene glycol, melaleuca alternifolia (tea tree) leaf oil, phenoxyethanol, potassium sorbate, purified water, simmondsia chinensis (jojoba) seed oil, sodium polyacrylate, stearic acid

  • Questions or comments?

    1-866-323-0107

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY: WALGREEN CO.
    200 WILMOT RD., DEERFIELD, IL 60015

  • PRINCIPAL DISPLAY PANEL - 56.7 g Tube Carton

    Walgreens

    Pain & Itch
    Relief Cream

    LIDOCAINE 4%

    NET WT 2 OZ (56.7 g)

    PRINCIPAL DISPLAY PANEL - 56.7 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    PAIN AND ITCH RELIEF   4% LIDOCAINE
    lidocaine cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-3001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Lidocaine (UNII: 98PI200987) (Lidocaine - UNII:98PI200987) Lidocaine0.04 g  in 40 g
    Inactive Ingredients
    Ingredient NameStrength
    aloe vera leaf (UNII: ZY81Z83H0X)  
    arginine (UNII: 94ZLA3W45F)  
    sulisobenzone (UNII: 1W6L629B4K)  
    cetyl alcohol (UNII: 936JST6JCN)  
    dimethyl sulfoxide (UNII: YOW8V9698H)  
    melaleuca alternifolia whole (UNII: 976KV4FXYF)  
    caprylyl glycol (UNII: 00YIU5438U)  
    potassium sorbate (UNII: 1VPU26JZZ4)  
    water (UNII: 059QF0KO0R)  
    hexylene glycol (UNII: KEH0A3F75J)  
    jojoba oil (UNII: 724GKU717M)  
    sodium polyacrylate (2500000 MW) (UNII: 05I15JNI2J)  
    stearic acid (UNII: 4ELV7Z65AP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-3001-241 in 1 CARTON01/15/2016
    156.7 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34801/15/2016
    Labeler - Walgreens (008965063)
    Establishment
    NameAddressID/FEIBusiness Operations
    Natureplex LLC062808196MANUFACTURE(0363-3001)

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